MAUDE Adverse Event Report: BAXTER REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Tachycardia (2095); Anxiety (2328); Diaphoresis (2452)

Event Date 07/04/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a patient (j.K., dob: (b)(6) 1959, male, estimated dry weight: 99kgs) received hd treatment with a revaclear 300 dialyzer but the patient had shortness of breath, diaphoretic, anxiety, and tachycardic (patient stated: "i am severely allergic to cats and it feels like i have had cats crawling on me.This is how i react to cats around me.").Therefore, the rn was going to run the patient with the baxter exeltra 150 dialyzer and note in his chart to only use the baxter exeltra 150 dialyzer from now on.The md was made aware of the situation.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REVACLEAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER
• MDR Report Key: 17526350
• MDR Text Key: 321043979
• Report Number: MW5133289
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 58 YR